DrugDashboards

Zoledronic Acid

Zoledronic Acid · ZOLEDRONIC ACID 5 mg/100mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0966-00 · 1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply. The price is down 28% over the past year, to $0.4774 per mL. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 2× the typical drug (0.1%).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$0.4774per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$3.36per billing unit (1 MG)HCPCS J3489 · Jul 1, 2026
  • Part D plans paid (avg)$1.48per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$0.25$0.5$0.75May 2024Sep 2026$0.4774
29 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$300.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 1 MG
$3.361
HCPCS J3489 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$12,249
231 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

18Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • price down 28% year over year+8
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for zoledronic acid (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 2× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $154.07 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA204217
TE code
AP
Approval date
Aug 18, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Zoledronic Acid (Injection, Solution)

LabelerStrengthFirst seenLast seen
Mylan Institutional LLCZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 3, 2026
Sagent PharmaceuticalsZOLEDRONIC ACID .04 mg/mLJul 15, 2026Sep 3, 2026
Dr. Reddy's Laboratories IncZOLEDRONIC ACID 4 mg/100mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories IncZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories LtdZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Eugia US LLCZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedZOLEDRONIC ACID .04 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.ZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsZOLEDRONIC ACID .05 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncZOLEDRONIC ACID 5 mg/100mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Zoledronic Acid — NDC 63323-0966-00," retrieved September 3, 2026, https://drugdashboards.com/drug/63323096600.

Free to cite with attribution — see how the data is put together.